A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer

A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI002-7P Treatment With or Without Tislelizumab in Borderline and Resectable Pancreatic Ductal Adenocarcinoma

The researchers are doing this study to find out whether ELI-002 7P in combination with mFOLFIRINOX, with or without tislelizumab, is a safe treatment approach in people who have pancreatic ductal adenocarcinoma (PDAC) with a KRAS mutation. In addition, the researchers are doing this study to find out whether the study treatment is effective against PDAC.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: ELI-002 7P; Drug: mFOLFIRINOX; Drug: Tislelizumab

Detailed Description

This is an open-label, multi-institution pilot study of neoadjuvant mFOLFIRINOX (5-Fluorouracil, oxaliplatin, leucovorin, irinotecan) and a lipid-conjugated Kristin-Ras (KRAS) therapeutic cancer immunotherapy (ELI-002 7P vaccine), with or without Tislelizumab, in patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eileen O'Reilly, MD; Phone Number: 646-888-4182
• Study Contact Backup: Name: Kevin Soares, MD; Phone Number: 212-639-3195; Email: soaresk@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
      • Contact: Kevin Soares, MD; Phone Number: 212-639-3195

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Documentation of Disease

• Pathologically confirmed adenocarcinoma of the pancreas.

• Presence of one of seven KRAS mutations: G12D, G12V, G12R, G12C, G12A, G12S, or G13D.

  • Definition of Disease

• Patients must have resectable or borderline resectable localized disease as defined by NCCN Guidelines v2.2025. Staging CT or MRI of the chest/abdomen/pelvis at enrollment must be negative for metastatic disease.

  • Prior Treatment

• Up to 4 doses of neoadjuvant mFOLFIRINOX are allowed prior to enrollment. Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade

  1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2), alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator).

  • Age ≥18 years.
  • ECOG Performance Status 0-1
  • Pregnancy and Nursing
• Not pregnant or breastfeeding.

• Evidence of post-menopausal status or a negative urinary or serum pregnancy test for females of child-bearing potential within 28 days prior to initiation of treatment.

  • Required Organ Function
  • Hematologic function:
• ANC ≥1,500/mm³
• Platelets ≥100,000/mm³

• Hemoglobin ≥8.0 g/dL

  • Renal function:

• Creatinine clearance ≥50 mL/min (Cockcroft-Gault formula or 24-hour urine collection).

  • Hepatic function:
• Total bilirubin ≤1.5 × ULN (Gilbert's syndrome allowed up to ≤3 × ULN)

• AST and ALT ≤3 × ULN Albumin: ≥2.5 g/dL

  • Cardiac function: Patients with known cardiac disease or prior exposure to cardiotoxic agents should undergo risk assessment per NYHA classification; patients must be class or better. Compliance and Life Expectancy
  • Patient is willing and able to comply with protocol procedures, treatment, and follow-up.

• Estimated life expectancy of at least 12 weeks per treating physician.

  • Comorbid Conditions
• No active infection requiring parenteral antibiot ic(s)

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

  • Allergies: No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
  • Concomitant Medications

• Concomitant medication use should only exclude patients when clinically relevant drug-drug interactions or overlapping toxicities are expected to impact safety or efficacy. All concomitant medications from 7 days prior to screening through 12 weeks after the last dose of investigational product must be documented in the medical record.

  • Contraception Requirements
• Patients of reproductive potential must use highly effective contraception from screening through 90 days after the last dose of immunotherapy.

Exclusion Criteria:

• Locally advanced unresectable PDAC (per NCCN v2.2025), including unreconstructable venous anatomy, arterial tumor contact ≥180° (superior mesenteric, celiac, or hepatic artery), or aortic invasion
• Metastatic PDAC.
• Prior treatment with TNF receptor agonists (OX40, CD27, CD137/4-1BB, GITR) or prior checkpoint inhibitor therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1).
• Active infection including tuberculosis, hepatitis A, active HBV (HBsAg+), or active HCV. Patients with resolved HBV (anti-HBc+, HBsAg-) may enroll. HCV Ab+ patients are eligible if HCV RNA PCR is negative. Successfully treated cholangitis is not exclusionary if no active infection remains.
• Known HIV infection not meeting the on-study guideline criteria above.
• Active or prior documented autoimmune/inflammatory disorders including: IBD, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, systemic sclerosis, CNS or motor neuropathy of autoimmune origin (e.g., Guillain-Barré, myasthenia gravis, multiple sclerosis). Exceptions: vitiligo, alopecia, stable hypothyroidism on replacement, remote (>5 years) inactive autoimmune disease, or celiac disease controlled by diet.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic CHF, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, interstitial lung disease, serious GI conditions with chronic diarrhea, or psychiatric/social situations limiting compliance.
• Current or prior systemic immunosuppressive medication within 14 days of first ELI-002 7P dose.
• Exceptions: intranasal/inhaled/topical steroids, local steroid injections, physiologic replacement doses (≤10 mg prednisone/day or equivalent), steroids as premedication for imaging contrast allergy, or limited steroid use as anti-emetic with mFOLFIRINOX.
• Receipt of a live attenuated vaccine within 30 days prior to first dose of immunotherapy.
• Pregnancy, breastfeeding, or unwillingness to use effective contraception during treatment and for 90 days after last immunotherapy dose.
• Allergy or hypersensitivity to study drugs or excipients.
• Any other malignancy within 3 years except adequately treated cervical carcinoma in situ, non-muscle-invasive bladder cancer, localized prostate cancer, or non-melanoma skin cancers.
• Prior allogeneic organ transplantation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ELI-002 7P concurrent with mFOLFIRINOX; Participants receives ELI-002 7P during adjuvant chemotherapy.	Drug: ELI-002 7P; a subcutaneous (SC) injection under the skin; Drug: mFOLFIRINOX; neoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan)
Experimental: Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX.; Participants will receive Ttislelizumab IV every four weeks concurrent with ELI-002 7P.	Drug: ELI-002 7P; a subcutaneous (SC) injection under the skin; Drug: mFOLFIRINOX; neoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan); Drug: Tislelizumab; s an intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of patients with a Grade 3 or higher drug-related adverse event (AE)	according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Lustgarten Foundation; Elicio Therapeutics; BeOne Medicines; Breakthrough Cancer
• Investigators: Principal Investigator: Kevin Soares, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Tislelizumab; ELI-002 7P; 25-386
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; tislelizumab
• Other Study ID Numbers: 25-386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No